Non-small Cell Lung Cancer Clinical Trial
Official title:
A Phase 1 Dose-Escalation Pharmacokinetic and Pharmacodynamic Study of TG01 Tablets in Combination With Erlotinib in Non-Small Cell Lung Cancer Patients
Verified date | March 2010 |
Source | Tragara Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This is a multicenter, open-label, phase 1, dose escalation study. The purpose is to determine the highest dose of TG01 that can be safely given to patients with Non-Small Cell Lung Cancer in combination with erlotinib.
Status | Completed |
Enrollment | 45 |
Est. completion date | November 2009 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria (include but are not limited to): - Histogically or pathologically determined relapsed/recurrent Stage IIIb (plueral effusion) or IV NSCLC. - Measurable or evaluable disease as defined by RECIST - Must have failed at least one prior chemotherapy regimen or have refused chemotherapy. - ECOG perfromance status of 0,1, or 2. Exclusion Criteria (include but are not limited to): - Radiation therapy (excluding CNS therapy) < 2 weeks, chemotherapy, non-cytotoxic investigational agents or high dose corticosteroids within 3 weeks of intitating therpy or patients who have not recovered from adverse effects due to agents administered more than 3 weeks earlier. - Evidence of New York Heart Associatation Class III or greater cardiac disease. - History of myocardial infarction, stroke, or cardiovascular intervention within the last 12 months. - Patients on anti-platlet drugs or anticoagulants such as Placix and Coumadin. - Systemic central nervous system metastases. The patient must be stable after radiotherapy for >/= to 2 weeks and off corticosteroids for >/= to 1 week. - Pregnant or nursing women. - Patients who are primarily refactory to erlotinib. |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United States | Comprehensive Blood and Cancer Center | Bakersfield | California |
United States | City of Hope | Duarte | California |
United States | Nevada Cancer Institute | Las Vegas | Nevada |
United States | University of Southern California | Los Angeles | California |
United States | University of California at Davis | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
Tragara Pharmaceuticals, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Saftey, maximum tolerated dose, optimal biological dose and pharmacokinetics. | Baseline, 8, 15 and 28 days | No |
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